Status:
RECRUITING
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Bristol Myers Squibb Company (BMS)
Conditions:
Ischemic Stroke; Ischemic Attack, Transient
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
Eligibility Criteria
Inclusion
- Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (\<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (\>=) 6
- Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
- Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
- A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion
- Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (\>) 1 year prior with adequate treatment
- The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
- The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial \[TOAST\] Other Determined Etiology), based on local standard-of-care investigations
- Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
- Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
- Known allergies, hypersensitivity, or intolerance to milvexian or its excipients
Key Trial Info
Start Date :
February 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 9 2026
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT05702034
Start Date
February 15 2023
End Date
December 9 2026
Last Update
March 13 2026
Active Locations (874)
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1
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
2
University of Arizona
Tucson, Arizona, United States, 85721
3
Plaza Neuroscience Clinic
Fayetteville, Arkansas, United States, 72703-3902
4
Alta Bates Medical Center Cancer Center
Berkeley, California, United States, 94705